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US FDA requests data on 25 high-risk device types on the market since 1976

This article was originally published in RAJ Devices

Executive Summary

The US Food and Drug Administration has told manufacturers of certain types of high-risk medical devices that have been on the market since 1976 – before such devices were subject to a rigorous premarket approval process to establish safety and effectiveness – to submit additional information about their products1. High-risk (Class III) medical devices that have since been approved by the FDA on the basis of being substantially equivalent to these pre-1976 device types are also covered by the new order.




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